The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants
NCT ID: NCT01897922
Last Updated: 2015-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
348 participants
INTERVENTIONAL
2013-07-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Marketed routine infant formula
Control: Marketed routine infant formula
Infant formula containing a probiotic source
An investigational infant formula containing a probiotic source
Interventions
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An investigational infant formula containing a probiotic source
Control: Marketed routine infant formula
Eligibility Criteria
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Inclusion Criteria
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula fed
* Signed Informed Consent and Protected Health Information
Exclusion Criteria
* Feeding difficulties or formula intolerance
12 Days
16 Days
ALL
Yes
Sponsors
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Mead Johnson Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Carol Lynn Berseth, M.D.
Role: STUDY_DIRECTOR
Mead Johnson Nutrition
Locations
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Birmingham Pediatric Associates
Birmingham, Alabama, United States
Greenvale Pediatrics Hoover
Birmingham, Alabama, United States
Southeastern Pediatric Associates
Dothan, Alabama, United States
Pediatrics East - Alabama Clinical Therapeutics
Pinson, Alabama, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States
Arkkansas Pediatric Clinic
Little Rock, Arkansas, United States
Norwich Pediatric Group, P.C.
Norwich, Connecticut, United States
Children's Research, LLC
Altamonte Springs, Florida, United States
Children's Medical Associations
Plantation, Florida, United States
Deaconess Clinical Research
Evansville, Indiana, United States
Owensboro Pediatrics
Owensboro, Kentucky, United States
Woburn Pediatic Associates
Woburn, Massachusetts, United States
Cary Pediatric Center, P.A.
Cary, North Carolina, United States
Capital Pediatrics & Adolescent Center
Raleigh, North Carolina, United States
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, United States
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, United States
Parma Pediatrics, Inc
Parma, Ohio, United States
UHMP Comprehensive Pediatrics
Westlake, Ohio, United States
The Jackson Clinic - North Jackson
Jackson, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Austin Diagnostic Clinic
Austin, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Countries
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References
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Berseth CL, Yeiser M, Harris CL, Kinnaman JN, Lappin V, Wampler JL, Zhuang W, Vanderhoof J. Infant formula with added Lacticaseibacillus rhamnosus GG supported adequate growth and was well tolerated in healthy term infants: a randomized controlled trial. Front Pediatr. 2024 Oct 23;12:1456607. doi: 10.3389/fped.2024.1456607. eCollection 2024.
Other Identifiers
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3385-2
Identifier Type: -
Identifier Source: org_study_id
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